Home NDC 68012-102 ZEGERID
Product NDC 68012-102
11-digit product format 680120102
Labeler code 68012
Product ID 68012-102_1d076bd0-8cc0-4327-8032-9a307fc89e71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name omeprazole and sodium bicarbonate
Dosage form CAPSULE
Route ORAL
Labeler Santarus, Inc..
Application NDA021849
Marketing category NDA
Marketing start 2006-02-27
Substance OMEPRAZOLE; SODIUM BICARBONATE
Active strength 20; 1100 mg/1; mg/1
Pharmacologic classes Alkalinizing Activity [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021849-001 ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27 N021849-002 ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021849-001 ZEGERID 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021849-002 ZEGERID 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021849-001 ZEGERID 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021849-002 ZEGERID 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021849-001 ZEGERID 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021849-002 ZEGERID 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL AB RLD 2006-02-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL AB RLD, RS 2006-02-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL AB RLD 2006-02-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL AB RLD, RS 2006-02-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL AB RLD 2006-02-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL AB RLD, RS 2006-02-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL AB RLD 2006-02-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL AB RLD, RS 2006-02-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL AB RLD 2006-02-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL AB RLD, RS 2006-02-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL AB RLD 2006-02-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL AB RLD, RS 2006-02-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ZEGERID
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OMEPRAZOLE 20 mg/1 SODIUM BICARBONATE 1100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8MDF5V39QO Internal UNII lookup KG60484QX9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 616539 Internal RxNorm lookup 616541 Internal RxNorm lookup 646344 Internal RxNorm lookup 646352 Internal RxNorm lookup 753557 Internal RxNorm lookup 753562 Internal RxNorm lookup 753601 Internal RxNorm lookup 753603 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68012-102-30 ZEGERID 30 in 1 BOTTLE CAPSULE 30 53
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OMEPRAZOLE ACTIVE INGREDIENT KG60484QX9 ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 SODIUM BICARBONATE ACTIVE INGREDIENT 8MDF5V39QO ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 BICARBONATE ION ACTIVE MOIETY HN1ZRA3Q20 ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 OMEPRAZOLE ACTIVE MOIETY KG60484QX9 ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 SUCROSE INACTIVE INGREDIENT C151H8M554 ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68012-102 ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [SANTARUS, INC..] 52 Current NDC, Legacy NDC, 1 package rows 20230729_cd6868b9-5824-442b-8d65-4db29ecb70a4.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 616539 omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule PSN cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753562 omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension PSN cd6868b9-5824-442b-8d65-4db29ecb70a4 53 616541 omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule PSN cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753557 omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension PSN cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646344 Zegerid 20 MG / 1100 MG Oral Capsule, Reformulated Aug 2006 PSN cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753603 Zegerid 20 MG / 1680 MG Powder for Oral Suspension, Reformulated Aug 2006 PSN cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646352 Zegerid 40 MG / 1100 MG Oral Capsule, Reformulated Aug 2006 PSN cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753601 Zegerid 40 MG / 1680 MG Powder for Oral Suspension, Reformulated Aug 2006 PSN cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646344 omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006] SBD cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753603 omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension [Zegerid Reformulated Aug 2006] SBD cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646352 omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006] SBD cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753601 omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension [Zegerid Reformulated Aug 2006] SBD cd6868b9-5824-442b-8d65-4db29ecb70a4 53 616539 omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule SCD cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753562 omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension SCD cd6868b9-5824-442b-8d65-4db29ecb70a4 53 616541 omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule SCD cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753557 omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension SCD cd6868b9-5824-442b-8d65-4db29ecb70a4 53 616539 Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646344 Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006] SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753562 Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral Suspension SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753603 Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral Suspension [Zegerid Reformulated Aug 2006] SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 616541 Omeprazole 40 MG / NaHCO3 1100 MG Oral Capsule SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646352 Omeprazole 40 MG / NaHCO3 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006] SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753557 Omeprazole 40 MG / NaHCO3 1680 MG Powder for Oral Suspension SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753601 Omeprazole 40 MG / NaHCO3 1680 MG Powder for Oral Suspension [Zegerid Reformulated Aug 2006] SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646344 Zegerid (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral Capsule, Reformulated Aug 2006 SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753603 Zegerid (omeprazole 20 MG / sodium bicarbonate 1680 MG) Powder for Oral Suspension, Reformulated Aug 2006 SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753601 Zegerid (omeprazole 40 MG / sodium bicarbonate 1680 MG) Powder for Oral Suspension, Reformulated Aug 2006 SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753603 Zegerid 20 MG / 1680 MG Powder for Oral Suspension, Reformulated Aug 2006 SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753601 Zegerid 40 MG / 1680 MG Powder for Oral Suspension, Reformulated Aug 2006 SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646344 Zegerid Reformulated Aug 2006 (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral Capsule SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646352 Zegerid Reformulated Aug 2006 (omeprazole 40 MG / sodium bicarbonate 1100 MG) Oral Capsule SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68012-102-30 68012010230 30 CAPSULE in 1 BOTTLE (68012-102-30) 30 capsule 2006-02-27 0000-00-00 No No Current